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Second Wind Air Purifier

by Monagan Ent., Inc.

510(k) K980745

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK980745 Date2 Apr 1999ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FRA
Device Class
Class II
Regulation
21 CFR Part 880.6500
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Second Wind Air Purifier is a medical ultraviolet air purifier designed for use within an HVAC system. It functions by utilizing ultraviolet technology to treat air circulating through the ventilation infrastructure.

This device is classified as a Class II medical device under regulation number 880.6500 and product code FRA. It has received FDA 510(k) clearance under K980745.

Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • How does the Second Wind Air Purifier function?

    This device operates by utilizing ultraviolet technology to treat air as it circulates through an existing HVAC ventilation infrastructure.

  • What is the regulatory status of this device?

    The Second Wind Air Purifier is a Class II medical device that has received FDA 510(k) clearance under submission number K980745.

  • Where is this air purifier intended to be installed?

    The device is specifically designed for use within an HVAC system, allowing it to treat air as it moves through the building's ventilation infrastructure.